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Project Persist: mHealth for Cancer Survivorship

NCT04126642 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2023-11-15

No results posted yet for this study

Summary

Many studies have shown that anxiety and depression are associated with reduced treatment adherence and poor treatment outcomes among patients undergoing cancer treatments. Given the negative consequences of psychological symptoms for cancer patients, it is important to effectively identify and address emotional distress among cancer patients. However, many barriers exist that limit access to effective treatments. Mobile health (mHealth) technologies offer the potential for remote monitoring and on demand management of psychological needs among cancer patients. This pilot randomized controlled trial (RCT) will assess the initial feasibility of a phone-delivered intervention for anxiety and depressive symptoms among cancer patients that are receiving active radiation treatments. A total of 60 participants will be randomized to in-person and smartphone-based assessment only (n=30) or assessment plus smartphone-based intervention (n=30). Both groups will be followed for 8 weeks (6 weeks while undergoing radiation therapy for breast or gynecological cancer + 2 weeks following radiation therapy). It is expected that patients who are randomized to the intervention group will report that the smartphone app is easy to use, app content is useful, and will show greater improvements in reported anxiety, depression, and quality of life compared with the assessment only group. Data from this pilot study will be used to inform the development of mHealth interventions that will be tested in future fully powered RCTs.

Conditions

  • Symptom Management
  • Reduce Treatment Non-adherence

Interventions

BEHAVIORAL

Assessment only group

Individuals randomized to this group will receive radiation therapy as usual plus baseline, follow-up, and EMA assessments.

BEHAVIORAL

Intervention group

Individuals randomized to the intervention group will complete the same measures (in person and daily EMAs) as the assessment only group, but will additionally receive messaging that is tailored to patient responses on EMAs.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2023-10-19
Completion
2023-10-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04126642 on ClinicalTrials.gov